Ortho VITROS 5600 Software Recall for Parameter Reset Defect
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below. The recall affects 2,617 units, including 1,272 in the United States and 1,344 in foreign countries. The affected serial number range is J56000114 through J56001879.
The recall was initiated because modifications to MicroWell Qualitative Assay Parameters are not retained and may be inadvertently reset to default settings in certain circumstances. This defect could impact the accuracy of test results.
The product was distributed nationwide in the U.S. and in 24 foreign countries, including Argentina, Australia, Brazil, Canada, China, and Japan. Users of the affected software versions should contact Ortho Clinical Diagnostics for further instructions on how to resolve the issue.
The recalled product
- Product
- VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
- Manufacturer
- Ortho Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Affected Serial Number Range : J56000114- J56001879
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Ortho Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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